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American Family Physician, the journal of the American Academy of Family Physicians, has a feature called AFP Journal Club, where physicians analyze a journal article that either involves a hot topic affecting family physicians or busts a commonly held medical myth. In the September 15, 2010 issue they discussed “Vaccines and autism: a tale of shifting hypotheses,” by Gerber and Offit, published in Clinical Infectious Diseasesin 2009.

Gerber and Offit reviewed 13 large-scale studies that demonstrated no association between the MMR vaccine and autism. These included ecologic studies, retrospective observational studies and prospective observational studies. The findings were consistent; the only outlier in all the studies of MMR was Dr. Andrew Wakefield’s small, discredited 1998 study, which was fully retracted by The Lancet in early 2010.

They reviewed 7 large-scale studies (again, ecologic, retrospective, and prospective) that consistently demonstrated no association between thimerosal and autism. They showed that the hypothesis was not biologically plausible, since the symptoms of mercury poisoning are distinct from those of autism and are not produced by the thimerosal in vaccines.

They showed that the overload hypothesis is not credible because

The immunologic load has dropped from 3000 components in the 7 vaccines used in 1980 to less than 200 in the 14 vaccines recommended today.

An infant’s immune system is capable of handling the thousands of antigens it is exposed to early in life.

One of the common arguments the anti-vaccine advocates use is the “toxins in vaccines” argument. They say that because some substance in vaccines is known to be toxic, such as aluminum, then its mere presence makes vaccines dangerous. What they fail to mention in almost every case however is how much of said substance is in vaccines, and at what levels is this substance toxic.

Water can be toxic to a human in high enough quantities; it’s called drowning. Oxygen can be poisonous; it’s called oxygen poisoning. The list of examples goes on and on but the take home point is this: any substance can be toxic in the right dose; and most substances will not be toxic at low enough levels. As they say the dose makes the poison. The same applies to aluminum.

So, how much aluminum is there in vaccines anyway, and is that level dangerous for babies? To answer that, the Vaccine Education Center at the Children’s Hospital of Philadelphia has set up a short, concise, informative PDF that is available to all, for free, titled “Aluminum in Vaccines: What you should know“. And unlike those in the anti-vaccine camp, the Vaccine Education Center provides all their sources in the PDF itself, for anyone who wants to verify the accuracy of their report.

What they report should satisfy everyone’s curiosity.

During the first 6 months of life, infants could receive about 4 milligrams of aluminum from vaccines. That’s not very much: a milligram is one-thousandth of a gram and a gram is the weight of one-fifth of a teaspoon of water. During the same period, babies will also receive about 10 milligrams of aluminum in breast milk, about 40 milligrams in infant formula, or about 120 milligrams in soy-based formula.

So to put this in perspective: a baby will get 2.5 times the amount of aluminum from breast milk, 10 times the aluminum from infant formula, and 30 times the aluminum from soy-based formula. I know of no babies that are raised without either breast milk or formula, including the babies of each person in the anti-vaccine camp, and any baby who wasn’t vaccinated due to parent’s fear of aluminum toxicity in vaccines.

It appears to me that the anti-vaccine crowd should switch its focus from “greening” vaccines to “greening” baby formula. I hear Big Formula makes a lot of money too out of its product….!

Not that this will settle anything, because science fact is not decided by arguments from popularity, but I think it is important to point this out. Many in the anti-vaccine community appeal to a “mommy knows best” argument, in which they will tell a very emotional story about how a mother saw their child fade away right after getting a vaccine. McCarthy herself has told her son’s story many times, telling us how she, to paraphrase, saw his soul fade away right after the vaccine. The implication is that mothers of autistic children know that their children’s autism is caused by vaccines.

Nevertheless, surveys do not support this notion. A survey of 62 families of autistic children found out that only 29% of parents of autistic children blame vaccines for their children’s autism (page 6). So if mothers know best, it appears McCarthy is in the minority within the community of parents of autistic children. It appears, at least from this survey, that about 70% of parents of autistic children do not blame vaccines for their children’s autism. So if the results of this survey hold, and can be extrapolated out to the entire population of parents of autistic children, which is quite a stretch to be honest, it would appear that for every mommy instinct blaming vaccines, there are two mommy instinct not blaming vaccines.

So what does this mean for the vaccines-autism “controversy”. Absolutely nothing; the correlation, or lack there of, between vaccines and autism is a scientific issue, not a popularity contest. The fact is what it is, regardless of what parents think, and I’m willing to say that even when parental opinion is on my side. Is Jenny McCarthy, and all the rest in the anti-vaccine community, willing to do the same? The answer to that question would shed so much light on their ability, and willingness, to find out the truth.

It is reasonable to ask how new vaccines are tested before they are cleared for public use. The National Institute of Allergy and Infectious Diseases explains the various studies that must be done before the new vaccine is approved by the FDA. There are various stages of testing a vaccine must undergo before it is cleared for use. They are as follows.

1) Animal Testing– Firstly, the new vaccine is tested in animals for safety and immunogenicity, meaning that is must be safe and induce enough of an immune response to justify moving on with human trials.

2) Phase I Study – After a promising animal test, the process moves to what is referred to as clinical trials, meaning testing in human subjects. The first step in this process is a Phase I study, which is the first setting in which an experimental vaccine is given to people. The trial, which can last up to 2 years, may enroll between 20 to 100 volunteers. A Phase I study primarily seeks information on safety, particularly looking for any vaccine-related side effects. The study can also provide data on the dose and administration schedule needed to achieve the optimal immune responses.

3) Phase II Study – Once Phase I studies show the experimental vaccine is safe, well tolerated, and appears promising, it can advance into Phase II. These studies, which can last longer than 2 years, enroll between 100 to 300 volunteers. In these studies researchers gather more data on safety and immunogenicity. These studies also test the effects of varying the doses, and are also referred to as dose-ranging studies.

4) Phase III Study– The most promising vaccine candidates move into Phase III, enrolling 10,000 or more people. A Phase III study, which can last up to 4 years, is typically designed to ensure enough data are collected on safety and effectiveness to support a license application to FDA.

An intermediary study, called a Phase IIb study is being considered, as a middle step between the Phase II and the Phase III studies. This study would enroll between 2,000 and 9,000 volunteers. It appears, as of the time of writing, that Phase IIb studies are not a requirement like the others.

Besides the required tests, the FDA may require additional testing and data at any point. Furthermore, the proposed manufacturing facility undergoes a pre-approval inspection during which production of the vaccine as it is in progress is examined in detail. Vaccine approval also requires the provision of adequate product labeling to allow health care providers to understand the vaccine’s proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public.

Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 studies-formal studies on a vaccine once it is on the market. Also, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins. The VAERS system and how it works is discussed further on this website.

Today we will look at the recent recommendation by the CDC, the American College of Obstetricians and Gynecologists, that, all people over 6 months of age, including pregnant women receive the flu vaccine. Anti-vaccination groups have already come out, insinuating that the safety of the flu vaccine given during a woman’s pregnancy has not been established. Is that true? Are there any studies that have looked at the safety of the influenza vaccine for pregnant women? The answer is yes, at the very least there is one that I was able to find, using simply Google.

Study Summary – The objective of the study was to “evaluate the safety of influenza vaccine that is administered in the second or third trimester of gestation”. A retrospective electronic database search of 5 influenza seasons (July 1, 1998, to June 30, 2003) was performed at a large multispecialty clinic in Houston, Texas. Immunization rates were calculated, and outcomes of pregnancy were compared between healthy women who received influenza vaccine, and a control group of healthy unvaccinated women who were matched by age, month of delivery, and type of medical insurance.

Results – Among 7183 eligible mother-infant pairs, only 252 pregnant women (3.5%) received the influenza vaccine. The mean gestational age at the time of influenza vaccination was 26.1 weeks (range, 14-39 weeks). No serious adverse events occurred within 42 days of vaccination, and there was no difference between the groups in the outcomes of pregnancy (including cesarean delivery and premature delivery) and infant medical conditions from birth to 6 months of age.

Conclusion – This study provides good evidence that pregnant women who receive the flu vaccine during the last 2 trimesters of the pregnancy, and their babies at least up to 6 months of age, face no more risks or complications than pregnant women who do not receive the flu shot during the last 2 trimesters of their pregnancy, and their babies up to 6 months of age. It appears the claims of the anti-vaccination crowd are rejected, at least as far as this study is concerned. The authors concluded as such:

Influenza vaccine that was administered in the second or third trimester of gestation was safe in this study population.

Common vaccinations don’t raise risk of rheumatoid arthritis, easing fears that they’re linked to the inflammatory disease, according to a new study.

Case reports have suggested vaccines, possibly because of their immune-activating adjuvants, could trigger rheumatoid arthritis, a painful autoimmune disease caused by the body’s natural defenses attacking and inflaming joints.

But a study published online Tuesday in the Annals of the Rheumatic Diseases found no link between common vaccinations for flu, hepatitis, diphtheria and other illnesses and an increased risk for rheumatoid arthritis. The study also found no increased risk for patients getting vaccinations who had a genetic susceptibility to the disease, or who were smokers. Smoking has long been thought to be a major risk factor for the disease.

Receiving multiple vaccines also didn’t up the chances of getting afflicted by the joint disease.

“Our results indicate that immunological provocation of adults with common vaccines in their present form is not a major risk factor for RA,” write the authors, led by Camilla Bengtsson, a researcher at the Karolinska Institute in Stockholm, Sweden. “In addition, our results indicate that active immunization does not increase the risk of RA in individuals with established risk factors.”